Newron Pharmaceuticals announced that the FDA has placed a hold on the enrollment of new patients at U.S. sites participating in the company’s Phase III ENIGMA‑TRS 2 study of evenamide in treatment‑resistant schizophrenia. The hold applies only to ENIGMA‑TRS 2 centers in the United States; the global ENIGMA‑TRS 1 study, which is also part of the ENIGMA‑TRS program, continues and has enrolled more than 400 patients.
The FDA action followed Newron’s notification to the agency of a sudden death of a study participant at a clinical site outside the United States. According to Newron, the trial investigator assessed the event as unrelated to study treatment, and the company informed the independent international safety monitoring board overseeing the ENIGMA‑TRS program. The safety monitoring board reviewed the event and recommended that the ENIGMA‑TRS studies proceed as designed.
ENIGMA‑TRS 2 is a 12‑week, randomized, double‑blind, placebo‑controlled Phase III study evaluating the efficacy, tolerability and safety of evenamide 15 mg twice daily versus placebo in patients with treatment‑resistant schizophrenia. The trial is being conducted at sites in the United States and selected additional countries, with at least 400 patients planned for enrollment. ENIGMA‑TRS 2 was initiated in the U.S. in December 2025 following FDA and Institutional Review Board approvals, and has also received regulatory approval in Argentina and India, with approvals in Colombia and Malaysia in final stages.
Newron stated that it is working with the FDA and intends to provide the information requested by the agency to resolve the enrollment hold and enable resumption of enrollment at U.S. sites in ENIGMA‑TRS 2.
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